(58 days)
Not Found
No
The document describes quality control and calibration verification materials for existing diagnostic tests and meters. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is a quality control and calibration verification material used with diagnostic tests, not a therapeutic device that treats or diagnoses a medical condition.
No.
Explanation: The device description states that the product consists of "quality control materials" and "calibration verification materials" used to "monitor test performance" and "verify the calibration of the Test Devices." It explicitly states, "The quality control materials are not calibrators and are not used to calibrate the Triage Test Devices." These materials are for ensuring the accuracy and reliability of diagnostic tests, not for directly diagnosing medical conditions.
No
The device description clearly states the device is a physical material (liquid controls and calibration verification materials) prepared with biological components and stored frozen. It is not software.
Based on the provided text, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the materials are "to be used with the Triage® Profiler S.O.B.™ Panel, Triage CardioProfilER® Panel, Triage Cardiac Panel, Triage BNP Test, Triage D-Dimer Test and the Triage Meters to assist in monitoring test performance" and "to verify the calibration of the Test Devices". These are activities performed in vitro (outside the body) to assess the performance of diagnostic tests.
- Device Description: The description details the composition of the materials, which are prepared with biological components (purified CK-MB, myoglobin, troponin I, BNP and D-Dimer and human EDTA plasma) and are used to evaluate the performance of diagnostic tests.
- Intended User / Care Setting: The intended user is "laboratory and professional use," which aligns with the typical use of IVD quality control and calibration verification materials in a clinical laboratory setting.
- Predicate Device: The mention of a predicate device (K040459) which is also described as "Controls and the Triage® Profiler S.O.B. Calibration Verification Controls" further supports that this device falls under the category of IVD quality control and calibration verification materials.
These characteristics clearly indicate that the device is intended for use in vitro to provide information about the performance of diagnostic tests, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Triage Total Controls 5 are assayed materials to be used with the Triage® Profiler S.O.B.™ Panel, Triage CardioProfilER® Panel, Triage Cardiac Panel, Triage BNP Test, Triage D-Dimer Test and the Triage Meters to assist in monitoring test performance.
The Triage Total Calibration Verification 5 materials are to be used with the Triage Profiler S.O.B.™ Panel, Triage CardioProfilER® Panel, Triage Cardiac Panel, Triage BNP Test, Triage D-Dimer Test and the Triage Meters to verify the calibration of the Test Devices throughout the measurable range.
Product codes
JJY
Device Description
The Triage Total Controls 5 Control 1 and 2, and Triage Total Calibration Verification 5 Levels A, B, C, D, E are single-use, 0.29 mL unit dose quality control materials prepared with concentrated purified CK-MB, myoglobin, troponin I, BNP and D-Dimer and human EDTA plasma at defined levels. The controls are stored frozen at
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
510(k) Summary of Safety and Effectiveness B.
Triage® Total Controls 5 / Triage® Total Calibration Verification 5
This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is:
1. Name and Address of Submitter
DEC 0 7 2007 Company Name: Biosite Incorporated Address: 9975 Summers Ridge Road San Diego, CA 92121 Telephone: (858) 805-2722 Telefax: (858) 586-7543 Fil V. Buenviaje Contact Person: Sr. Manager, Regulatory Compliance Date Summary Prepared: October 5, 2007
2. Device Name and Classification
| Trade Name: | Triage® Total Controls 5
Triage® Total Calibration Verification 5 |
|---------------------------|-------------------------------------------------------------------------------------------|
| Common Name: | Not Applicable |
| Classification of Device: | 21 CFR 862.1660,
Quality Control Material (Assayed and Unassayed)
Product Code: JJY |
3. Predicate Devices
K040459 - Triage® Profiler S.O.B. (Shortness of Breath) Controls and the Triage® Profiler S.O.B. Calibration Verification Controls
Device Description 4.
The Triage Total Controls 5 Control 1 and 2, and Triage Total Calibration Verification 5 Levels A, B, C, D, E are single-use, 0.29 mL unit dose quality control materials prepared with concentrated purified CK-MB, myoglobin, troponin I, BNP and D-Dimer and human EDTA plasma at defined levels. The controls are stored frozen at Trade Name: Triage® Total Controls 5, Triage® Total Calibrator Verification 5 Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: October 5, 2007 Received: October 16, 2007
Dear Mr. Buenviaje:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and 809); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
3
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.v.M.
Jean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name:
Triage® Total Controls 5 Triage® Total Calibration Verification 5
Indications for Use:
The Triage Total Controls 5 are assayed materials to be used with the Triage® Profiler S.O.B.™ Panel, Triage CardioProfilER® Panel, Triage Cardiac Panel, Triage BNP Test, Triage D-Dimer Test and the Triage Meters to assist in monitoring test performance.
The Triage Total Calibration Verification 5 materials are to be used with the Triage Profiler S.O.B.™ Panel, Triage CardioProfilER® Panel, Triage Cardiac Panel, Triage BNP Test, Triage D-Dimer Test and the Triage Meters to verify the calibration of the Test Devices throughout the measurable range.
Prescription Use (Per 21 CFR 801.109) x AND/OR
Over-The Counter Use (Per 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol C. Benson
Division Sign Off
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safetv Page 1 of
510(k) K072892